Official Title: “Phase III Study of a Double-Blind Randomized Comparison of Famotidine Plus Celecoxib Versus Dologesics for Gastric Ulcer Healing in Arthritis Patients (NSAID#5A Study)”

The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: August 2009

For many years the integrity of the stomach mucosal barrier is thought to be maintained by mucosal prostaglandins (PG) synthesized by COX-1. However, the notion that COX-1 protects the stomach and COX-2 induces inflammation may be over-simplistic. In animal studies, COX-2, but not COX-1, is expressed in experimental gastric ulcer. Inhibition of COX-2 delays ulcer healing, indicating that PG derived from COX-2 contributes to restoring the mucosal barrier [1]. Whether this animal observation can be generalized to the human stomach is unknown. To date the biological functions of COX-1 and COX-2 in the healing of human gastric ulcer healing is unclear. Unlike experimental ulcers that only express COX-2, recently we have shown that both COX-1 and COX-2 are up-regulated in human gastric ulcers [2]. Furthermore, our preliminary results suggest that inhibition of COX-2 alone may not lead to a clinically significant delay in ulcer healing (refer to progress report). These observations suggest that peptic ulcer healing is more complex in the human stomach - both COX isoforms may be involved in the healing process. Inhibition of COX-2 alone may have less adverse effect than non-selective inhibition of both COX isoforms in ulcer healing. The current study aims to resolve the functional significance of COX-2 in human gastric ulcer from a biological and clinical perspective.

Intervention(s) in this Clinical Trial

• Drug: celecoxib
  • Celecoxib 200mg bd
• Drug: Dologesics
  • Dologesics 2 tablets bd

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Celecoxib + Famotidine
• Active Comparator: 2
  • Dologesics + Famotidine

Primary Measures

• ulcer healing
  • Time Frame: 8 weeks
    

Inclusion Criteria:

• Gastric ulcers confirmed by endoscopy
• Stop taking NSAIDs for 1 week prior to endoscopy
• Age 18
• H. pylori negative
• Informed written consent

Exclusion Criteria:

• Actively bleeding ulcers
• Ulcers showing dysplasia or malignancy
• Renal failure (serum creatinine >200umol/l)
• Previous gastric surgery
• Moribund or terminal malignancy
• Concomitant use of proton pump inhibitor, misoprostol, aspirin, steroid or anticoagulant

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chinese University of Hong Kong

Overall Clinical Trial Officials and Contacts

Francis K Chan, MD Principal Investigator Chinese University of Hong Kong  

Overall Contact: Francis K Chan, MD 85226323143 fklchan@cuhk.edu.hk

Information obtained from ClinicalTrials.gov on January 07, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00153673

Study ID Number: 5NA study

ClinicalTrials.gov Identifier: NCT00153673

Health Authority: Hong Kong: Department of Health